Trial Resources

These documents and resources are for use by collaborators involved in the REACT-AVB trial. They are the property of the University of Birmingham and do not constitute any form of advice to participants. Please contact the Trial Office if you require printed versions of any of the documents.

 

Training and Webinar Presentation

Introductory webinar Presentation v1.0 (Powerpoint Presentation 3,019KB)

Site set-up

The following table outlines the documents required/ tasks that require completing, in order for a site to progress towards Green Light approval.
 
 

Document

Responsibility

Completed Localised Organisation Information Document (OID)

(ONLY SECTIONS 1 – 18 REQUIRE COMPLETION)

Initially completed by R&D, however may need further input from research team

Completed mNCA Document (not signed)

Initially completed by R&D, then further input from research team to allocate site number before signatures requested

Completed Delegation Log

PI/research team

Confirmation of capacity and capability

R&D

Trust logo and contact details for localised documents

Research team (BCTU to localise)

Letters of Access/Honorary Contracts for staff not directly employed by the site

PI/ research team

Protocol signature page, signed by the PI

PI

Research CV (signed within the last 12 months) and current GCP certificate for the PI

PI

Research CV (signed within the last 12 months) and current GCP certificate for the aPI (if appointed)

aPI

CVs/GCP certificates for other staff performing research activity for the trial at your site

Research team

Confirmation PI and aPI (if appointed) has review of the pre-recorded video presentation of the SIV slides

PI and aPI

Confirmation of other staff performing research activity for the trial at your site has review of the pre-recorded video presentation of the SIV slides

Research team

Confirmation of PI and aPI (if appointed) attending a live virtual Q&A session

PI and aPI

Address for delivery of ISF

Research team

 

Associate PI Scheme

The trial is also registered for the Associate PI Scheme and will be available to receive Associate PI trainee applications from 30/09/2023. Applicants will be able to register to be Associate PI trainees for this study from 30/09/2023 having obtained approval from their local PI. Potential Associate PI trainees can find details on how to apply on the Associate PI Scheme website here.

Site Initiation Q&A Sessions

 The site initiation Q&A sessions are for sites currently in set up and working towards Green Light Approval. They provide an opportunity for site staff to further build on the training delivered in the site initiation presentation slides, and to ask any questions to the BCTU Trial Team or Chief Investigator/ Co-Chief Investigator. Where at all possibe, we request that you please register for the Q&A sessions at least 24 hours prior to the call commencing, to ensure BCTU/ CI support is available for the call.

Days and Dates of Q&A Sessions

Times

 Registration Link

Thursday 8th August 2024

13:00 – 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZApdOmvqDkjHND-65qcGm5lQG6NH1xe7oAB

Monday 9th September 2024

12:00 – 13:00

 https://bham-ac-uk.zoom.us/meeting/register/tZUlcuqpqj0rGNf090hMDUsNHDfDaijSYRdJ

Thursday 19th September 2024

13:00 - 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZMsc-mqrzwtHNQULibdrUbt4evZGBD6A0jS

Monday 23rd September 2024

13:00 – 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZYkdumrqDgoGdC2N0Wm3L-DFS6ckC9fQ_a5

Thursday 3rd October 2024

13:00 – 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZAvduyhqTkvHte9_xt6sCK52oYRhThKqvmH

Thursday 17th October 2024

13:00 – 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZwvcOChqT0rE9RCI_ZNJZVcjCvN4C3WNG1n

Monday 21st October 2024

13:00 - 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZ0uc--spjkiGNFpgprQqc3_4xwsyrNtloGS

Thursday 7th November 2024

13:00 – 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZEtdOmvpz4iH9W16J2r112y0xD8dF33IMhs
Thursday 21st November 2024

13:00 - 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZEkdemoqDssG9PyCpQjWjoFirZZ9T0v5tS6
Thursday 28th November 2024

13:00 – 14:00

 https://bham-ac-uk.zoom.us/meeting/register/tZYlc-CsrDgqGdzsQ2OZpkuAhWRtwHrFNlfA
Monday 2nd December 2024

13:00 – 14:00

 https://bham-ac-uk.zoom.us/meeting/register/tZAudeCorjguH9JZjBrAfkb6ldyVwMj3qyeq
Monday 16th December 2024

13:00 – 14:00

 https://bham-ac-uk.zoom.us/meeting/register/tZUrdOitqTorG9yaweiqsJFNcDvrNhehNTEd

Open Site Drop In Sessions

Drop in sessions are available for sites with Green Light Approval and actively recruiting.  They provide an opportunity for open discussion and to share best practice.  We request that you please register for a drop in session at least one hour prior to the call commencing to ensure BCTU support is available for the call.

Days and Dates of Drop In Sessions

Times

 Registration Link

Wednesday 18th September 2024 13:00– 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZEvcumsqDsrHNVT6ocZHFq04vdDo4ZZweQi

Tuesday 15th October 2024

13:00– 14:00

https://bham-ac-uk.zoom.us/meeting/register/tZMpdOuhrT0iEteRrXDozJHQc47spnLVoibL

Monday 18th November 2024

13:00– 14:00

 https://bham-ac-uk.zoom.us/meeting/register/tZUoc-iorz4sHNMf3YowBTEhydd4PgXjq06I

Publications

The REACT-AVB Trial protocol was published in BMJ Open Gastroenterology on the 22nd March 2024 and the paper can be accessed by following the link below: 

https://bmjopengastro.bmj.com/content/11/1/e001314

Frequently Asked Questions

Which type of site will you recruit from?

We will be recruiting patients from acute NHS Trusts and Health Boards in the UK that admit and manage patients with acute variceal bleeding.

Has a recruitment target been confirmed?

The recruitment target is 294 patients across 30 sites in the UK.  We expect sites to recruit three or more participants per year. If this is not possible, please do reach out to the team to discuss further with the CI.

When is the recruitment end date?

28/02/2028.

When is the end date for the study activities?  (i.e. “last patient visit” completed and study is ready to be archived.)

28/08/2029.

The dates provided above have been projected based upon the first site opening.  Please note that the trial has an internal pilot (1 year) and any decision going forward will be based on how the pilot goes and if we move to full trial. For further information regarding the progression criteria for the pilot, please see section 2.1 of the Protocol.

Has the study been adopted by the CRN?

Yes.

Is there any pharmacy/ CRF/ CRF labs involvement?

There is no CRF/Labs/pharmacy involvement. The main delivery team is imaging.

Will blood samples be sent to the trial’s office? 

No, these will be classed as standard of care and sites will only be required to record the results onto the CRF.

Can you confirm that all blood tests taken are standard of care and there is no requirement for any additional local lab processing?

Yes. Blood tests are standard of care and there is no requirement for any additional local lab processing.

Which blood tests do I need to record on the Baseline CRF?

We advise that the most recent standard of care bloods are used within a 48h timeframe prior to randomisation.

Are any devices to be provided for the study?

No devices are required or will be provided for the trial.

Does this trial require ARSAC approval?

No. Radiation Assurance approval is in place and will be provided to all sites within their Local Information Pack.

Will staff only perform a diagnostic endoscopy if there is suspected bleeding, or can there be other reasons a diagnostic endoscopy has been performed?

Whilst the index endoscopy will be performed due to a history of bleeding, subsequent endoscopies may be carried out for several reasons i.e. where bleeding is suspected, as part of the banding programme in the SoC arm, or if there is a crossover from SoC to the TIPSS arm.

Does a patient have to be actively bleeding at the time of endoscopy?

No.

Which members of staff need to be listed on the delegation log? Should the Radiologist and Anaesthetist performing the TIPSS procedure be included?

The research staff listed on the delegation log should be those who are able to undertake the tasks outlined in the log.  It is the responsibility of the PI to confirm that those that are listed on the delegation log are qualified to undertake such activities.  All tasks listed on the delegation log must be covered by at least one member of staff at a site for Green Light approval to be granted.  We do suggest that sites may want to add sub-investigators (for if the PI is not available) and ideally a senior gastroenterology/hepatology colleague. This is particularly important when covering causality review during adverse event reporting.  As the TIPSS procedure is carried out within routine care, an interventional radiologist/ITU consultants/ anaesthetist is not required on the delegation log.

For the Associate PI Scheme, can there be two or more simultaneous Associate PI (aPI) Trainees who are amid their 6-month tenure, at the same site, at the same time?

Most PIs will only mentor one aPI Trainee at a time. However, if you as the local PI are happy to mentor more than one aPI Trainee at a time then NIHR will allow this. We are led by the capacity of the local PI.  If a site has the capacity to support multiple aPIs, please contact the BCTU trial office to confirm and we will inform the NIHR team.

What training is involved to participate in the REACT-AVB trial?

The Research Team are required to watch the pre-recorded Site initiation Training slides.  The PI and aPI (if one appointed) are also required to attend a Q& A session after watching the pre-recorded video.  We will encourage the rest of the team to attend the Q&A session, but this is not mandatory.